Cardiovascular Disease Risk Calculation
Why are the ASCVD risk calculator results different than Framingham calculator results?
Different risk calculators estimate the likelihood of different cardiovascular events and are derived from different data. This results in different predicted risks.
The ASCVD risk calculator is derived from multiple cardiovascular cohorts with more diverse populations, and estimates the likelihood of heart attack, stroke, or cardiovascular death among whites and African Americans.
The Framingham calculators are derived from data in the Framingham population and estimate the likelihood of different outcomes depending on which calculator you choose.
Commonly estimated outcomes include:
hard CHD events (heart attack and CHD death)
total CHD events (angina, heart attack, and CHD death)
TIA and stroke
In calculating cardiovascular risk, it is always important to:
Choose a calculator that predicts outcomes of interest.
In this program (and in emerging guidelines), the focus is on ASCVD risk.
Treat according to appropriate risk thresholds (e.g. those derived from the outcome of interest and the relevant benefits and harms of any potential treatment)
Document the predicted outcome you calculate and follow this outcome over time
What should I do if my patient’s age falls outside the suggested age range for risk calculation?
The risk calculator was developed for patients ages 40-79. The calculator is less reliable for patients outside this age range and a different approach is needed. If your patient is less than age 40 and does not have diabetes, smoking or high blood pressure, they are unlikely to have a high ASCVD risk in the next 10 years that would warrant aspirin or statin therapy. In that case, you should encourage a healthy diet and exercise – see our resources.
If your patient is older than 79, they are likely to be at high ASCVD risk, but are also at higher chances of harm. Based on guidelines from the USPSTF aspirin is not recommended in this age group due to insufficient evidence about the balance of benefits and harms. The decision about the use of statins should be individualized in this age group, based on personal preferences.
What should I do if risk factors fall outside the suggested range for risk calculation?
If risk factors fall outside the suggested range for risk calculation, the calculator will not allow risk calculation. In this case you should use the closest risk factor value that falls within the risk factor range for risk calculation.
Because you are now estimating risk rather than using measured risk information to predict risk, you will need to alert patients to the potential error in their risk estimate.
Should I calculate risk if my patient has subclinical atherosclerosis?
Sometimes patients have no prior history of cardiovascular events, but have subclinical atherosclerosis (e.g. coronary artery calcium on CT). See Pletcher et al., 2013.
It is still appropriate to calculate ASCVD risk in patients with subclinical atherosclerosis.
Calculating cardiovascular risk is a more cost-effective approach to risk reduction than treating subclinical atherosclerosis.
Blood Pressure Measurement
Where can I find information on which models of BP monitors have been validated?
A great resource is the following website: www.dableducational.org
What is the difference between home BP monitoring and ambulatory BP monitoring?
With home BP monitoring, the patient uses her own (or a loaned) monitor to take intermittent BP measurements. The patient should be instructed to take measurements in a systematic manner using proper technique. When used to clarify BP diagnosis or control, a recommended approach is to have the patient record three measurements in the morning and three measurements in the evening over a period of 5 to 7 days. A diary (or the device’s memory) displaying the recorded measurements can then be used to discern whether the patient’s average BP is elevated or whether a certain percentage of readings are elevated.
With ambulatory BP monitoring, the patient wears a device placed by a clinic that provides the service. The device is set to automatically record BPs at prespecified intervals (usually every 15 to 30 minutes during the awake hours and every 30 to 60 minutes during sleep) over a 24-hour period. Readings are not visible to the patient. Software is used to download the readings from the device and generate a report that displays BP averages over the course of the day and night.
For a review of ambulatory blood pressure monitoring and home blood pressure monitoring, see the following article: http://www.ncbi.nlm.nih.gov/pubmed/26457954
What do I do when office BP measurement is elevated but the patient says her BP is “normal“ at home or at a pharmacy kiosk?
Pharmacy kiosk devices are generally not recommended as reliable sources of BP measurements. If a patient is using a validated home BP monitor correctly and is systematic about collecting (and showing you) the readings, it is reasonable to base decisions on home BP monitoring. Remember that the "normal" cutoff for home BP average is 135/85 mm Hg. It is recommended to document in the chart that patient’s home BP average.
Treatment of High Blood Pressure
Are thiazide diuretics okay for patients with gout?
The decision to use thiazide-type diuretics in patients with a history of gout should be individualized. Thiazides slightly increase the serum uric acid level in a dose-dependent fashion. At the typically used low doses, uric acid increases by about 0.8 mg/dL or less in patients with normal kidney function. Thiazide-type diuretics are low-cost and effective, and they work synergistically with ACEIs/ARBs and CCBs. For many hypertensive patients, avoiding or discontinuing a thiazide may limit ability to control BP, which is a key contributor to CVD events and chronic kidney injury in patients with gout. However, if you are unable to control the patient’s gout, you should consider switching the thiazide to another class of medication, such as an ARB, which is slightly uricosuric.
Reference: McAdams DeMarco MA, Maynard JW, Baer AN, et al. Diuretic use, increased serum urate levels, and risk of incident gout in a population-based study of adults with hypertension: the Atherosclerosis Risk in Communities cohort study. Arthritis Rheum 2012; 64:121–129.
Why are we recommending chlorthalidone as the thiazide-type diuretic of choice?
Chlorthalidone was the thiazide-like diuretic used in the large clinical trials with patient-oriented outcomes, including the recent SPRINT Trial. It is longer-acting and provides greater BP reduction than equivalent doses of hydrochlorothiazide. Additionally, compared to hydrochlorothiazide, it reduces progression to left ventricular hypertrophy and cardiovascular events to a greater degree. Remember that thiazide diuretics are only effective when renal function is adequate. In patients with a serum creatinine value >1.8 mg/dL or glomerular filtration rate (GFR) <30 mL/min, a loop diuretic should be used.
What about "compelling indications" for selecting certain anti-hypertensive medications?
Patients with certain comorbidities benefit from specific antihypertensive drug classes. For example, patients who have experienced a myocardial infarction should be receiving β-blocker treatment unless it is not tolerated. Patients with chronic kidney disease should be receiving treatment with either an ACE-inhibitor or ARB
What should be our approach to medication dosing for patients who require multiple anti-hypertensive medications?
In the hypertension treatment webinar, we presented data from a meta-analysis of 354 trials of blood pressure lowering drugs (thiazides, B blockers, ACE-inhibitors, ARBs, and calcium channel blockers) that demonstrated that there is little additional benefit to using twice the standard dose (compared to the standard dose) of a single antihypertensive medication and that three drugs at half the standard dose resulted in a 20/10mmHg reduction in BP. Therefore, we recommend using moderate doses of different medications in combination, as opposed to high doses of a single medication.
How should diuretics be modified in patients with chronic kidney disease (CKD)?
Because of the reduction in renal function, higher doses of diuretics are typically required in patients with CKD who are usually volume expanded even in the absence of edema. Thiazides are less effective when eGFR is <30cc/min. In these patients, loop diuretics (e.g. Furosemide) may be preferred over thiazides or used in addition to thiazide diuretics. If using Furosemide, it should be dosed twice daily.
What is the SPRINT trial and what did it show?
The SPRINT (Systolic Blood Pressure Intervention Trial) trial was a randomized control trial or over 9000 persons which was designed to answer the basic research question of “how low should we go with respect to systolic blood pressure reduction.” The hypothesis was that a lower SBP goal (e.g., <120mmHg) would reduce clinical events more than a standard goal (<140mmHg). To be enrolled in the SPRINT trial, participants had to be at least 50 years old, have a systolic blood pressure of 130-180mmHg, and an increased risk of cardiovascular events. Increased cardiovascular risk was defined by clinical or subclinical cardiovascular disease other than stroke; chronic kidney disease (based on estimated glomerular filtration rate); a 10-year risk of cardiovascular disease of 15% or greater based on the Framingham risk score; or an age of 75 years or older. Patients with diabetes mellitus or prior stroke were excluded from the Sprint trial. The primary composite outcome for the trial was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.
The SPRINT trial demonstrated that carefully administered and more intensive pharmacotherapy can reduce events, but it must be done carefully given the risk of adverse events. At 1 year, the mean SBP was 121mmHg in the intensive treatment group and 136mmHg in the standard-treatment group (i.e. there was about 15mmHg difference in SBP that was maintained throughout the trial). There was a 25% reduction in the intensive treatment group compared to the standard treatment group in the primary composite outcome and all-cause mortality was 27% lower in the intensive treatment group compared to the standard treatment group. The trial was stopped early after a median follow-up of 3.26 years due to a significantly lower rate of the primary composite outcome. Rates of serious adverse events of hypotension, syncope, electrolyte abnormality, acute kidney injury or failure, but not injurious falls, were higher in the intensive treatment group than in the standard-treatment group.
A couple of key points to remember: 1) BP was carefully and appropriately measured according to the American Heart Association guidelines (using an approach that is often not used in “real world” clinical practices) and no BP decisions were based on a single BP measurement ; 2) the average number of medications in the intensive treatment group was 2.8 compared to 1.8 medications in the standard-treatment group; and 3) the SPRINT results are likely only applicable to a relatively small percentage of the US population in general or of the population of patients with treated hypertension. (Bress AP et al. Generalizability of results from the Systolic Blood Pressure Intervention Trial (SPRINT) to the US adult population, Journal of the American College of Cardiology. 2015). In summary, the Sprint trial supports our recommendation of aiming for a BP of <140/90 and. in some patients who fit the higher cardiovascular risk profile, you could aim for a lower BP goal.
References: 1) The SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. NEJM. November 9, 2015; 2)Bress AP et al. Generalizability of results from the Systolic Blood Pressure Intervention Trial (SPRINT) to the US adult population, Journal of the American College of Cardiology. 2015
Are all "$4" generic retail drug programs about the same or should my patient "shop around" for the best deal?
Not all “$4” generic drug programs are the same so your patients should shop around for the best deal. You can find these programs by googling “retail prescription drug list.” Not all pharmacies have the same formulary, so it is worthwhile to shop around. In addition, some pharmacies use a “tier” system for assigning costs of the medications, such that the cost increases as the ‘tier” increases.
NC Medicaid also has a preferred drug list that allows NC Medicaid to obtain better prices for covered outpatient drugs through supplemental rebates. The link for this list is: http://www2.ncdhhs.gov/dma/pharmacy/PDL.pdf
How does literacy impact medicine adherence?
Those with low literacy are more likely to misunderstand their medicines than those with higher literacy.
Individuals at all literacy levels have more difficulty demonstrating the use of their medicines than in stating how to use them (only 35% of those with low literacy and 80% of those with high literacy can demonstrate correct medicine use). They also both misinterpret warning labels on medicines (Davis et al., 2006).
How Does Medicine Dosing Affect Adherence?
Increasing the number of doses of medicine per day, decreases adherence.
Claxton, 2oo1. Clin Therapeutics 23: 1296-1310.
Osterberg, 2005. JAMA 353: 487-97
Using medicines dosed once or twice per day is more likely to result in adherence than using medicines dosed more frequently.
How Can I Assess Patient Understanding for Medicine Use?
Patients frequently misunderstand how to take their medicines.
To assess patient understanding of medicine use, ask patients to:
Bring medicines to an appointment
Read and re-state medicine instructions
Take pills from the bottle as they would throughout the day when they take their medicine
Explain any special instructions they must follow, including those on the back of their bottle
What can I do to improve my patients understanding of their medicines?
There are two important things you can do to aid patient understanding of their medicines.
First, when possible, be more specific about when patients should take their medicines.
Using a universal medicine schedule (see below) for prescribing and bottle labels can improve both patient understanding and adherence to medicines.
Second, use of teach back (or teach to mastery) techniques, can improve understanding and adherence.
Teach back techniques ask patients to “re-state medicine instructions to ensure that providers explained them well enough” and then correct any misunderstanding (see the video on our website)
Bailey SC, Sarkar U, Chen AH, Schillinger D, Wolf MS. Evaluation of language concordant, patient-centered drug label instructions. J Gen Intern Med. 2012;27(12):1707-13. doi:10.1007/s11606-012-2035-3
Wolf MS, Curtis LM, Waite K, et al. Helping patients simplify and safely use complex prescription regimens. Arch Intern Med. 2011;171(4):300-5. doi: 10.1001/archinternmed.2011.39
Wolf MS, Davis TC, Curtis LM, et al. Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use. Med Care. 2011;49(1):96-100. doi: 10.1097/MLR.0b013e3181f38174
What resources are available for my patients who can’t afford their medicines?
For over the counter medicines,
Try buying in bulk from price clubs.
For prescription medicines, consider:
Partnership for prescription assistance at www.pparx.org or 1-877-447-2669
$4 lists at pharmacies
Talking with your financial counselor about other options
What resources are available to help my patients remember to take their medicines?
Multiple resources are available to help patients remember their medicines.
Medicine charts and calendars
Phone reminder systems
Statins for Primary Prevention
Do patients need to be fasting to check their lipid levels?
Accurately estimating cardiovascular risk does not require fasting measurements. Ordering total and HDL cholesterol levels, both of which are stable in the fasting or non-fasting state, provides the information needed for the ASCVD risk calculator.
However, for decision making about whether to use statins, some guidelines (including those used to develop Heart Health Now measures) base their recommendations on LDL cholesterol level. In the past, LDL cholesterol was estimated indirectly (using the Friedwald equation) based on total and HDL cholesterol plus triglyceride level. Triglycerides do vary depending on whether the patient is fasting or not, and hence required obtaining a fasting lipid profile. However, there is no compelling reason to check triglycerides routinely.
More recently, newer analytic techniques have allowed direct measurement of LDL cholesterol. This new technology (called "direct LDL") does not require fasting. As such, we generally recommend that providers obtain a non-fasting lipid panel (total and HDL cholesterol) plus direct LDL cholesterol.
The main caveat is that in some laboratories, direct LDL testing (or a non-fasting panel including it) is substantially more expensive than the fasting panel. If that is the case, providers should weigh the convenience of not requiring fasting against the increased out of pocket costs of direct LDL.
Do providers still need to regularly monitor liver function tests for patients on statins?
Statin drugs sometimes produce small elevations in liver enzyme tests (AST and ALT). However, an extensive amount of data from multiple trials and observational studies demonstrate that statins never, or only very rarely, cause any liver dysfunction or damage.
As such, recent AHA-ACC guidelines do not recommend routine monitoring of liver function tests. As a practical matter, clinicians may opt to check liver enzymes before starting statins, mainly to have a baseline value for interpretation in case future liver function elevations occur and the question arises about whether they are related to the statin.
If clinically significant elevations in liver enzymes are noted with statins, the particular statin can be discontinued, and another statin used in place of it, as the effect may not recur with a different agent.
Do I need to check lipid levels to make sure my patient reaches certain treatment goals?
Prior guidelines have emphasized the idea of treating to certain goal LDL levels. However, the most recent AHA-ACC guidelines have not emphasized LDL treatment goal levels for primary prevention, for several reasons:
randomized trials that provide evidence of benefit from statin therapy did not compare a goal-based treatment regimen against another regimen. Instead, they generally compared a fixed, moderate-dose statin against placebo.
while meta-analyses have generally found that larger reductions in LDL are associated with greater reductions in CVD events, primary prevention studies have not evaluated the effect of high-dose statins compared against moderate dose. Evidence from high risk secondary prevention trials do suggest some incremental benefit from high dose statins, but the difference, even in a high risk population, is relatively small.
to reach treatment goals, providers may feel a need to add other classes of lipid–lowering drugs beyond statins. Such approaches for primary prevention have not been studied and could be associated with an increased risk of muscle-related adverse events.
My patient reports muscle pain since he started taking statins. What should I do?
Case reports and observational studies suggest that 10% or more of statin takers report some degree of muscle pain. In contrast, double-blinded, placebo-controlled trials (some of which have pre-trial run-in periods that may have excluded some participants prone to muscle pain) suggest small or no increased risk of serious muscle damage. How much of the symptoms reported in observational studies is co-incidental versus truly related to statin use is still unclear.
If a patient develops new muscle pain soon after starting statins, we suggest the use of an evidence-based algorithm to help determine if the pain is related to the statin, and to help find an alternative approach (e.g. different dose, different statin, other lipid lowering agent, or no therapy) appropriate for the patient. The algorithm provides general guidance, but clinicians should use their own clinical judgment in deciding the best approach for a given patient.
How do the results from the HOPE3 trial affect our approach to use of statins for primary prevention?
Since we published our webinar on statins for primary prevention, the results of the large HOPE3 trial were published in New England Journal of Medicine. Overall, the HOPE3 results validated our risk-based approach to statin use, and provided some useful insight into a couple of questions about how to best direct statin use. In the section below, we describe the HOPE3 results in greater detail.
HOPE3 was a multinational, 2x2 factorial trial that examined the effect of statin (10 mg of rosuvastatin) on CVD events in patients at "intermediate risk." They randomized over 12,000 patients to statin vs placebo, and followed outcomes over a median of 5.6 years. Men who were 55 years of age or older and women who were 65 years of age or older and had at least one of the following cardiovascular risk factors were eligible:elevated waist-to-hip ratio, history of a low level of high-density lipoprotein cholesterol, currentor recent tobacco use, dysglycemia, family history of premature coronary disease, and mild renal dysfunction. We also included women 60 years of age or older who had at least two such risk factors.
Those assigned to statin had a 26% reduction in LDL cholesterol, compared with those assigned to placebo. More importantly, those assigned to statin use had a 24% reduction in CVD events (3.7% vs. 4.8%; hazard ratio, 0.76; 95% CI 0.64 to 0.91). Relative risk reduction was similar across CVD risk levels, lipid levels, and levels of C-reactive protein. In terms of adverse effects, cataract surgery was more common with statin use (3.8% vs. 3.1%, p = 0.02), as were muscle symptoms (5.8% vs. 4.7%; P = 0.005).
The results of HOPE3 add additional evidence suggesting that the relative risk reduction achieved with given potency of statin is similar across a diverse range of patients. In this trial, there was no difference in relative effect based on initial LDL level, CVD risk, or CRP level. These findings reinforce that a strategy that identifies patients for treatment based on assessment of CVD risk can be used to target therapy for those most likely to benefit, and that the absolute benefits are proportional to the underlying risk. Furthermore, while CRP may help better classify risk, it does not influence the relative risk reduction achieved with statins, as was suggested by secondary analyses of an older trial (AFCAPS). It should also be noted that the CVD event reduction achieved with rosuvastatin was consistent with the reduction in LDL observed, and that other, less expensive statins can be predicted to achieve the same degree of event reduction if they are dosed to achieve a similar reduction in LDL.
Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, López-Jaramillo
P, Leiter LA, Dans A, Avezum A, Piegas LS, Parkhomenko A, Keltai K, Keltai M,
Sliwa K, Peters RJ, Held C, Chazova I, Yusoff K, Lewis BS, Jansky P, Khunti K,
Toff WD, Reid CM, Varigos J, Sanchez-Vallejo G, McKelvie R, Pogue J, Jung H, Gao
P, Diaz R, Lonn E; HOPE-3 Investigators. Cholesterol Lowering in
Intermediate-Risk Persons without Cardiovascular Disease. N Engl J Med. 2016 Apr
2. [Epub ahead of print] PubMed PMID: 27040132
What do you recommend when age appears to be the primary driver in a patient with > 10% ASCVD risk? What are recommendations for statin use for those over 75 years of age?
Age is clearly a strong driver of ASCVD risk: both coronary heart disease (CHD) and stroke are more common at older ages. However, there is little evidence from randomized trials to inform us whether statins are effective in adults over age 75, including those whose other risk factors are not abnormal.
There is some evidence that cholesterol may be less associated with ASCVD outcomes in the elderly. Others have suggested that statins may be less effective in older adults and that some adverse effects, such as myopathy, may be more common. As such, we recommend individualized decision-making in older adults with only modest levels of ASCVD risk, particularly those with relatively normal risk factors.
Krumholz HM, Seeman TE, Merrill SS, et al. Lack of association between cholesterol and coronary heart disease mortality and morbidity and all-cause mortality in persons older than 70 years. Jama. Nov 02 1994;272(17):1335-1340.
Odden MC, Pletcher MJ, Coxson PG, et al. Cost-effectiveness and population impact of statins for primary prevention in adults aged 75 years or older in the United States. Annals of internal medicine. Apr 21 2015;162(8):533-541.
Is there a recommended Shared Decision Making tool that you suggest?
There have been a couple of decision aids that have been developed and tested for decision making about primary prevention of cardiovascular disease. One good example is: https://statindecisionaid.mayoclinic.org/
Should you re-calculate risk after you start statin therapy? If so, how often? What about times when a patient's ASCVD calculator result recommends they should not be on statin but they are on a statin?
Generally, the ASCVD risk calculator is designed to be used in advance of starting treatment. The Pooled Cohort Equations that power the ASCVD calculator are based on event rates in patients not on statins. However, there is reasonable evidence to suggest that the calculated risk obtained after therapy is a reasonable approximation of the residual risk. If you do re-calculate risk after initial therapy, it is quite possible that the post-treatment risk will be below 5%. This is an indication that the treatment is effective.
That said, we do not specifically recommend periodic re-calculation of risk to guide assessment of the effectiveness of statin therapy. It is a good idea to check in with the patient about any difficulty in maintaining adherence. It is also reasonable to check lipids after 3 months of therapy to ensure that the patient has obtained the 40-50% reduction in LDL expected with a moderate dose statin.
Can you speak to the risk of diabetes with statin therapy, and how that should play into our decision making, especially in patients who are pre-diabetic or at risk for developing diabetes?
A recent meta-analysis of major statin trials (both primary and secondary prevention) suggests a small (relative risk 1.09) increase in risk of diabetes with statin therapy. Another recent analysis from the systematic review commissioned for the USPSTF found a slightly smaller effect for trials of primary prevention (relative risk 1.05). In either case, the absolute increase in patients meeting the criterion for diabetes will be small.
It is important to also remember that “diabetes” is defined by somewhat arbitrary thresholds of (hyper) glycemia. Whether the modest increase in average glucose levels with statins is clinically meaningful is unclear.
Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16. PubMed PMID: 20167359
Chou R, Dana T, Blazina I, Daeges M, Jeanne TL. Statins for Prevention of Cardiovascular Disease in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016 Nov 15;316(19):2008-2024. doi: 10.1001/jama.2015.15629. Review. PubMed PMID: 27838722
Anything new with CNS effects (including confusion, risk of cognitive impairment, or risk of dementia) and statins?
The best evidence available to date does not identify adverse cognitive effects from statin use. In the recent USPSTF-commissioned review, the risk of cognitive events was lower with statin therapy.
Chou R, Dana T, Blazina I, Daeges M, Jeanne TL. Statins for Prevention of Cardiovascular Disease in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016 Nov 15;316(19):2008-2024. doi: 10.1001/jama.2015.15629. Review. PubMed PMID: 27838722
Effect of family history- should it be a part of risk calculation and should it be used to decide about statin therapy?
A “first-degree” (mother, father, sister, brother) family history of early onset coronary artery disease (particularly early onset myocardial infarction) is associated with an increased risk of coronary events, independent of other risk factors. However, the additional risk from having a family history of coronary disease is modest, and hence most risk calculators do not include it, as it does not improve risk classification substantially. In a patient near a treatment threshold, a positive family history may be one factor that supports treatment vs. observation.
Why do guidelines differ on treatment threshold for statins in primary prevention?
The AHA-ACC guidelines recommend treatment of adults ages 40-79 whose 10 year ASCVD risk exceed 7.5%; the USPSTF recommends treatment of adults 40-75 with at least one CVD risk factor whose risk is 10% or greater. The USPSTF recommends individualized, shared decision making for those at lower ASCVD risk (“C” recommendation). There are several reasons for the difference in recommendations:
- The two guideline groups may have different assessments of the benefits and harms of under- and over-treatment, leading to differences in thresholds for action.
- The AHA-ACC recommendations used one threshold level (7.5%) while the USPSTF made two divisions (B recommendation for >10%, C for 7.5-10%), with shared decision making.
- Emerging concern for the potential over-estimation of risk with the Pooled Cohort Equations may warrant a higher threshold in order to overcome this limitation.
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines.. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2015 Dec 22;132(25):e396. Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. PubMed PMID: 24222016
US Preventive Services Task Force. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Nov 15;316(19):1997-2007. PubMed PMID: 27838723
Should we treat patients with very low cholesterol levels but high CVD risk?
The trials that have demonstrated the effectiveness of statins for primary prevention have generally enrolled patients with elevated LDL cholesterol levels, mostly greater than 130 mg/dl. However, in trials of higher risk patients, including secondary prevention, the benefit of statins for reducing CVD events is present even in patients with lower initial LDL levels. Furthermore, a recent meta-analysis found similar levels of relative risk reduction across initial LDL levels. As such, it is reasonable to consider statin use for primary prevention in patients with high ASCVD risk but without elevated LDL levels. In such cases, it is important to acknowledge the limits of evidence in a shared decision making conversation, as well as considering other risk-reducing interventions (e.g. smoking cessation, blood pressure treatment)
Collins R, Reith C, Emberson J, Armitage J, Baigent C, Blackwell L, Blumenthal R, Danesh J, Smith GD, DeMets D, Evans S, Law M, MacMahon S, Martin S, Neal B, Poulter N, Preiss D, Ridker P, Roberts I, Rodgers A, Sandercock P, Schulz K, Sever P, Simes J, Smeeth L, Wald N, Yusuf S, Peto R. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet. 2016 Nov 19; 388(10059):2532-2561. PubMed PMID: 27616593
Tobacco Use Assessment and Treatment
If I recommend higher levels of Nicotine Replacement Therapy (NRT) like the patch plus gum or lozenges, won’t my patients risk overdosing?
The cigarette is basically a drug delivery system and people who smoke already self-dose nicotine on a daily basis. When instructed to watch for signs of too much nicotine (e.g., dizzy, lightheadedness, headache, nausea) they will know when to cut back. The greater risk often is in under-dosing and continuing to smoke, or giving up trying to quit because “it didn’t work.”
My patient says she has tried the nicotine patch (or gum, lozenge) before but it didn’t work. What should I suggest?
Sometimes people reduce use of NRT too quickly. Patients should not step down until they have been completely tobacco free for 4-6 weeks initially and for at least two weeks each time they step down. Adding nicotine gum or lozenge to a patch allows you to find the right nicotine replacement dosing to help them be completely tobacco free. If patients have used NRT correctly and at high enough doses, but are still smoking a few cigarettes, other options include adding bupropion or trying varenicline.
Will smoking while wearing the patch cause my patient to get sick or have heart problems?
Heart problems come from smoking, not from nicotine replacement. If the goal is to quit smoking, patients should do their best not to smoke while wearing the patch. However, if patients feel a need to smoke, they should be instructed to leave the patch on and notice what happens when they smoke. If they feel normal, they almost certainly need to increase their amount of nicotine replacement. If they experience symptoms, e.g., nausea, lightheadedness, dizziness, headache, they should be strongly encouraged to associate the negative effects with the cigarette, and to stop all smoking. If they intend to continue smoking, they should decrease or stop NRT.
What if my patients resist using Nicotine Replacement Therapy (NRT) because they believe that it would just be trading one addiction for another?
NRT products have much lower risk of addiction than cigarettes. This is because the amount of nicotine is delivered more slowly. The nicotine in NRT is also regulated by the Federal Drug Administration (FDA). It is estimated that less than 10% of people using nicotine gum continue using for longer than 6 months. Should a patient become addicted to NRT, behavioral therapies can be helpful in weaning off. Almost certainly, chewing nicotine gum is less harmful than continuing to smoke.
Silagey C, Lancaster T, Stead L, Mant D, Fowler G. 2004. Nicotine replacement therapy for smoking cessation. Cochrane Database Sys Rev: DC000146.
What if my patients say they can’t afford tobacco cessation medication?
A chart with costs of medication can be found in the resource section of our website. The Affordable Care Act states that patients should receive medication with no copay. Sorting out the grandfathered plans can be frustrating, and some insurance companies have not yet fully complied with rulings. However, resources exist:
NC Medicaid covers tobacco cessation medications as follows:
Prescription medications: bupropion (Wellbutrin, Zyban) and varenicline (Chantix).
OTC nicotine patch, gum, or lozenge are covered with a prescription, including combination therapy.
Nicotrol Inhaler or Nasal Spray need prior authorization that at least 2 of the medications listed above (a. and b.) were not effective.
Patients with Medicare and Medicaid can receive these benefits.
The NC Quitline offers free NRT to people who enroll in the program. As of Nov 2015:
State Employee Health Plan members can receive 12 week supplies of nicotine patches, gum, or lozenge, or combination if the Quitline counselor recommends.
Those with Medicaid, Medicare, or uninsured can receive 2 week supply of nicotine patches.
Lowest everyday prices OTC generic NRT are found at Target and Walmart. Other pharmacies often run specials, and there are sometimes coupons for brand name products. Note that Target and CVS do not sell cigarettes or other tobacco products, so they are good places to send patients to eliminate cues related to seeing cigarettes.
Pfizer Pathway program (www.PfizerRxPath.com) gives assistance for qualifying patients to help cover Chantix, Nicotrol Inhaler, or Nicotrol Nasal Spray.
How do I treat a patient with comorbid mental health or substance use disorders?
Patients with mental health or substance use disorders smoke at higher rates than the general population and also have more difficulty in quitting. It is a myth, however, that people with substance abuse or mental health conditions do not want to quit and that they cannot quit. They need more support, and can benefit from the same cessation medications and behavioral strategies as other patients. They may need higher dosing and use medications for a longer time. Smoking increases the rate of metabolism of some psychotropic medications, so patients who quit smoking should talk with their doctor about the doses of such medications after quitting.
Evins AE, Cather C, Laffer A. Treatment of tobacco use disorders in smokers with serious mental illness: toward clinical best practices. Harv Rev Psychiatry. 2015 Mar-Apr;23(2):90-8. doi: 10.1097/HRP.0000000000000063.
Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res. 2015 Jun 11. pii: ntv127. [Epub ahead of print]
Do patients complain about being billed for counseling?
The great majority of patients appreciate it when their doctor spends time and offers to help them quit tobacco use. Occasionally a patient may ask about a charge for tobacco counseling, but this is less likely to happen if the patients feel their concerns have been heard and they have received guidance.
Aspirin for Primary Prevention
What increases my patients’ chances of bleeding on aspirin?
The chances of bleeding on aspirin increase with several factors:
Prior peptic ulcer disease or GI bleed
Any bleeding disorder
Chronic non-steroidal anti-inflammatory medicines
Other anti-platelet medicines (e.g. clopidogrel) and anticoagulants (e.g. warfarin, lovenox)
Does Enteric Coated Aspirin Reduce Bleeding?
Enteric coated aspirin does not reduce bleeding.
Aspirin has systemic effects on both the stomach and duodenum and enteric coating does not reduce these.
What if aspirin causes gastrointestinal bleeding?
If a patient develops significant gastrointestinal bleeding while taking aspirin for primary prevention, aspirin should be stopped and the cause of the bleeding diagnosed and treated. The decision about whether to re-start aspirin is a challenging one, and should take into consideration the potential benefits as well as the increased risk of recurrent bleeding..
Should I start a medicine to protect the stomach while I am taking aspirin?
Aspirin can cause stomach upset. Proton pump inhibitors can reduce GI upset and prevent GI bleeding. For patients at average risk (including no history of prior GI bleeding), it is generally not cost-effective to use proton pump inhibitors (e.g. omeprazole), to reduce the risk of gastrointestinal bleeding.
According to current guidelines, why do I need a life expectancy of 10 years in order to take aspirin?
Current guidelines from the US Preventive Services Task Force, take into account the benefits of aspirin for colorectal cancer prevention as well as cardiovascular disease prevention.
In order to realize the benefit of colorectal cancer prevention, aspirin needs to be taken for 10 years.
In order to realize the benefit of cardiovascular disease prevention, aspirin needs to be taken for 1-2 years.
Secondary Prevention of Cardiovascular Disease
What will it cost my patient to go to Cardiac Rehab?
It depends on the patient’s insurance. We recommend to contact the location where the patient will go to Rehab, based on the website: http://nccraonline.org
An example for the Cardiac Rehab at UNC Wellness Center:
Patients with private insurance typically pay copays from $15 to $75 per visit. With Medicare, patients are responsible for 20% coinsurance until their annual deductible is met. Many patients with Medicare also have secondary insurance which may pick up that 20%. Patients with Medicaid typically pay about $3.00 copay per visit.
Why do you recommend high dose atorvastatin over other statins for secondary prevention?
Current guidelines recommend moderate-high dose statins for secondary prevention in patients with CAD. These are based on the PROVE IT TIMI-22 trial (Cannon et al. NEJM. 2004;350:1495-1504), which showed that an intensive lipid lowering statin regimen with atorvastatin 80 mg daily reduced death and major cardiovascular events by 16% compared to pravastatin 40 mg daily with an absolute risk reduction of 3.9%. Rosuvastatin would be expected to perform similarly to atorvastatin but is currently not available as a generic and is therefore more expensive for most patients.
For patients that are unable to afford these medications, using high dose pravastatin is a reasonable next option because it still reduces cardiovascular events compared to placebo (CTT Collaboration. Lancet. 2010;376:1670-1681).
Do you recommend to treat patients with statins towards a specific LDL goal in secondary prevention?
Checking LDL after initiation of statin therapy may be warranted to assess the expected response, which should be at least 30% reduction of LDL cholesterol (CTT Collaboration. Lancet. 2010;376:1670-1681). Patients with CVD that are not responding to statin therapy as expected should be evaluated for adherence; if adherence is good and there is no problem with adverse effects, increasing the dose or using an alternate agent can be considered.
My patient just had a stent implanted and is taking Aspirin and clopidogrel. He is planning to undergo an elective procedure such as a tooth extraction or colonoscopy. The surgeon asks to stop dual-antiplatelet therapy because he is concerned about the bleeding risk. What should I do?
Do not stop dual-antiplatelet therapy. If dual-antiplatelet therapy is stopped after stent implantation, stent thrombosis can occur, which is usually catastrophic with short-term mortality of up to 25% and major myocardial infarction in up to 70% of cases (Honda et al. Circulation. 2003;108:2-5).
In some cases, the procedure may be conducted safely with continued therapy. If not, we recommend discussion with the patient’s cardiologist if it is felt that discontinuation or interruption of dual-antiplatelet therapy may be necessary for any procedure or if the patient has issues with bleeding within one year of stent implantation.